US2025069734A1PendingUtilityA1

System and method for implantable medical device remote programming

Assignee: PACESETTER INCPriority: Aug 23, 2021Filed: Nov 14, 2024Published: Feb 27, 2025
Est. expiryAug 23, 2041(~15.1 yrs left)· nominal 20-yr term from priority
G16H 40/67G16H 40/40G06F 8/65G16H 20/30H04L 9/0643H04L 9/0631H04L 9/302A61N 1/37252G06F 21/34H04L 9/0825A61N 1/37247H04L 9/3247A61N 1/37264A61N 1/37254
76
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Claims

Abstract

Computer-implemented methods and systems are provided that receive, at an implantable medical device (IMD), a programming package comprising a collection of configuration change requests, transaction credentials, and a signature indicative of a source of the programming package. The transaction credentials include a first hash of the collection of configuration change requests. The IMD validates an external device as the source by decrypting the signature using a key that is uniquely associated with the external device. The IMD verifies the transaction credentials and the configuration change requests of the programming package, and generates a second hash of the collection of configuration change requests. Responsive to both (i) the second hash matching the first hash and (ii) the transaction credentials and the configuration change requests being verified, the IMD executes the collection of configuration change requests to update an operating configuration of the IMD.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A system comprising:
 a medical device comprising a housing configured to be implanted within or worn by a patient and one or more processors disposed within the housing;   first and second external devices comprising respective controllers and communication circuits configured to provide asynchronous remote programming of the medical device, the first external device located remotely from the medical device,   the controller of the first external device configured to:
 obtain configuration change requests; 
 build a programming package that includes the configuration change requests; and 
 direct the communication circuit of the first external device to communicate the programming package to the second external device via a network; 
   the controller of the second external device configured to:
 store the programming package at least until the second external device establishes a communication session with the medical device; and 
 direct the communication circuit of the second external device to wirelessly communicate the programming package to the medical device; and 
   the one or more processors of the medical device configured to:
 receive the programming package from the communication circuit of the second external device; and 
 execute the configuration change requests to update an operating configuration of the medical device. 
   
     
     
         2 . The system of  claim 1 , wherein the first and second external devices are configured to provide the asynchronous remote programming by building the programming package at a first point in time and communicating the programming package to the second external device for storage for an intermediary period of time until the second external device and medical device establish the communication session. 
     
     
         3 . The system of  claim 1 , wherein the first external device includes a user interface and wherein to obtain the configuration change requests, the controller of the first external device is further configured to receive selections of the configuration changes at the user interface at a first point in time prior to the second external device and medical device establishing the communication session. 
     
     
         4 . The system of  claim 1 , wherein the first external device is configured to communicate the programming package to the second external device, at a first point in time, when the first external device is located remote from the medical device, and wherein the second external device is configured to communicate the programming package to the medical device, at a second point in time, when the second external device is located proximate to the medical device. 
     
     
         5 . The system of  claim 1 , wherein the controller of the first external device is further configured to obtain a transaction credential; and build the programming package by combining the configuration change requests and the transaction credential. 
     
     
         6 . The system of  claim 5 , wherein the one or more processors of the medical device are further configured to: verify the transaction credential and the configuration change requests within the programming package, and responsive to the transaction credential and the configuration change requests being verified, execute the configuration change requests to update the operating configuration of the medical device. 
     
     
         7 . The system of  claim 5 , wherein the controller of the first external device is further configured to generate a signature by encrypting the transaction credential using a first key that is uniquely associated with the first external device and build the programming package by combining the configuration change requests, the transaction credential and the signature. 
     
     
         8 . The system of  claim 7 , wherein the one or more processors of the medical device are further configured to: validate the first external device as a source of the programming package by decrypting the signature using either the first key or a second key that is uniquely associated with the first external device, wherein the first key or the second key used to decrypt the signature is stored within a memory of the medical device. 
     
     
         9 . The system of  claim 1 , wherein the controller of the first external device is further configured to generate a first hash of the configuration change requests, the first hash representing one of the transaction credentials. 
     
     
         10 . The system of  claim 9 , wherein the one or more processors of the medical device are further configured to: generate a second hash of the configuration change requests; and responsive to the second hash matching the first hash, execute the configuration change requests to update the operating configuration of the medical device. 
     
     
         11 . The system of  claim 1 , wherein the medical device is an implantable medical device configured to be subcutaneously implanted within the patient. 
     
     
         12 . A method for asynchronously remote programming a medical device, the method comprising:
 obtaining configuration change requests at one or more external devices;   building a programming package that includes the configuration change requests at the one or more external devices; and   storing the programming package at the one or more external devices at least until one of the one or more external devices establishes a communication session with the medical device;   establishing a communication session between the one of the one or more external devices and the medical device;   wirelessly communicating the programming package from the one of the one or more external devices to the medical device during the communication session; and   executing the configuration change requests to update an operating configuration of the medical device.   
     
     
         13 . The method of  claim 12 , wherein the one or more external devices includes first and second external devices, the first external device located remote from the medical device, the programming package built at a first point in time by the first external device and the programming package stored at the second external device for an intermediary period of time until the second external device and medical device establish the communication session. 
     
     
         14 . The method of  claim 12 , wherein the programming package includes a designated time for scheduling in advance when to transmit the programming package to the medical device. 
     
     
         15 . The method of  claim 12 , further comprising receiving selections of the configuration changes, at a user interface, at a first point in time prior to establishing the communication session between the one of the one or more external devices and medical device. 
     
     
         16 . The method of  claim 12 , wherein the one or more external devices includes first and second external devices, the first external device located remote from the medical device, the first external device configured to communicate the programming package to the second external device, at a first point in time, when the first external device is located remote from the medical device, and wherein the second external device is configured to communicate the programming package to the medical device, at a second point in time, when the second external device is located proximate to the medical device. 
     
     
         17 . The method of  claim 12 , further comprising obtaining a transaction credential; and building the programming package by combining the configuration change requests and the transaction credential. 
     
     
         18 . The method of  claim 12 , further comprising verify the transaction credential and the configuration change requests, at the medical device, and responsive to the transaction credential and the configuration change requests being verified, executing the configuration change requests to update the operating configuration of the medical device. 
     
     
         19 . The method of  claim 17 , further comprising:
 generating a signature by encrypting the transaction credential using a first key that is uniquely associated with the one or more external devices;   building the programming package by combining the configuration change requests, the transaction credential and the signature; and   validating, at the medical device, the one or more external devices as a source of the programming package by decrypting the signature using either the first key or a second key that is uniquely associated with the one or more external devices.   
     
     
         20 . The method of  claim 12 , further comprising:
 generating, at the one or more external devices, a first hash of the configuration change requests, the first hash representing one of the transaction credentials in the programming package;   generating, at the medical device, a second hash of the configuration change requests; and   responsive to the second hash matching the first hash, executing the configuration change requests to update the operating configuration of the medical device.

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